Because the benefit of high-dose chemotherapy with autologous HSCT as first-line therapy in patients with DLBCL remains controversial, researchers sought to compare the efficacy and safety of R-CHOP with rituximab plus high-dose sequential chemotherapy and autologous HSCT.

For the phase 3 study (ClinicalTrials.gov Identifier: NCT00355199), investigators enrolled 246 high-risk patients with a high-intermediate or high International Prognostic Index score. Participants were randomly assigned to receive R-CHOP or rituximab with high-dose sequential chemotherapy.

Results showed that clinical response rates were similar between treatment arms, with 78% of patients treated with R-CHOP achieving a complete response vs 76% of those given high-dose sequential chemotherapy and rituximab.

At a median follow-up of 5 years, investigators found that 3-year event-free survival was 62% and 65% with R-CHOP and sequential chemotherapy with rituximab, respectively (P =.83).

There were also no significant differences in progression-free survival (P =.12) or overall survival (P =.64) between the 2 treatment arms.